FDA Product Code
FDA Product Code BTT — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Anesthesiology
- 21 CFR Citation
- 868.5450
510(k) Clearances — 222 records · page 1 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262268 | Optiflow Oxygen Kit (AA484J) | Fisher and Paykel Healthcare Limited | 2026-08-27 | Special | PDF ↗ |
| K254078 | HVT 2.0 | Vapotherm, Inc. | 2026-04-13 | Traditional | PDF ↗ |
| K251448 | FL-10000U Respiratory Humidifier | Flexicare Medical Limited. | 2026-01-16 | Traditional | PDF ↗ |
| K251419 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2026-01-14 | Traditional | PDF ↗ |
| K253479 | Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) | Fisher & Paykel Healthcare, Ltd. | 2025-12-19 | Special | PDF ↗ |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | Medline Industries, LP | 2025-07-02 | Traditional | PDF ↗ |
| K251611 | Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE) | Fisher & Paykel Healthcare, Ltd. | 2025-06-25 | Special | PDF ↗ |
| K242717 | Laboratorios Biogalenic Sterile Water for Inhalation, USP | Laboratorios Biogalenic S.A. DE C.V. | 2025-01-30 | Traditional | PDF ↗ |
| K241778 | Hudson RCI Comfort Flo® CubCannula | Medline Industries, LP | 2024-12-19 | Traditional | PDF ↗ |
| K240163 | Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus Cannula | Medline Industries, LP | 2024-09-27 | Traditional | PDF ↗ |
| K234058 | F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) | Fisher & Paykel Healthcare, Ltd. | 2024-08-08 | Traditional | PDF ↗ |
| K233707 | HFT150 | Invent Medical Corporation | 2024-06-14 | Traditional | PDF ↗ |
| K233821 | F&P Optiflow Oxygen Kit (AA451J) | Fisher & Paykel Healthcare, Ltd. | 2024-06-13 | Traditional | PDF ↗ |
| K222292 | F&P myAirvo 3 | Fisher & Paykel Healthcare | 2024-05-08 | Traditional | PDF ↗ |
| K231956 | F&P Optiflow+ Duet Nasal Cannula | Fisher & Paykel Healthcare, Ltd. | 2024-02-07 | Traditional | PDF ↗ |
| K230559 | Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) | Medline Industries, Inc. | 2023-10-26 | Traditional | PDF ↗ |
| K223863 | BONHAWA Respiratory Humidifier | Telesair, Inc. | 2023-10-13 | Traditional | PDF ↗ |
| K223684 | F&P 820 Humidification System | Fisher & Paykel Healthcare, Ltd. | 2023-09-05 | Traditional | PDF ↗ |
| K231380 | AirLife DuoTherm Humidification System | Vyaire Medical, Inc. | 2023-08-10 | Traditional | PDF ↗ |
| K223551 | Sterile Water for Inhalation in 1L Flexoval ® bottles. | Hometa, Inc. | 2023-08-03 | Traditional | PDF ↗ |
| K220703 | F&P 950 Respiratory Humidifier | Fisher & Paykel Healthcare | 2023-06-16 | Traditional | PDF ↗ |
| K222197 | F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range | Fisher & Paykel Healthcare, Ltd. | 2023-04-06 | Traditional | PDF ↗ |
| K222351 | inspired VHB20 Heated Humidifier | Vincent Healthcare Products Limited | 2022-12-21 | Traditional | PDF ↗ |
| K212031 | F&P 850 AirSpiral Adult NIV and NHF Circuit Kit | Fisher & Paykel Healthcare, Ltd. | 2022-04-22 | Traditional | PDF ↗ |
| K211096 | Optiflow Oxygen Kit | Fisher & Paykel Healthcare, Ltd. | 2022-01-28 | Traditional | PDF ↗ |
| K203357 | HVT 2.0 | Vapotherm, Inc. | 2021-08-25 | Traditional | PDF ↗ |
| K201723 | F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling | Fisher & Paykel Healthcare, Ltd. | 2021-03-16 | Traditional | PDF ↗ |
| K193411 | O2asis Personal Oxygen Humidifier | Perma Pure, LLC | 2020-11-12 | Traditional | PDF ↗ |
| K191818 | F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) | Fisher & Paykel Healthcare, Ltd. | 2020-03-19 | Traditional | PDF ↗ |
| K191010 | Palladium High Flow Therapy System | Vapotherm, Inc. | 2019-10-10 | Traditional | PDF ↗ |
| K162553 | AirSpiral Heated Breathing Tube | Fisher & Paykel Healthcare | 2018-12-20 | Traditional | PDF ↗ |
| K180474 | TNI softFlow 50 | Tni Medical AG | 2018-10-18 | Traditional | PDF ↗ |
| K161719 | Salter Labs Bubble Humidifier | Salter Labs | 2017-09-21 | Traditional | PDF ↗ |
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | Hamilton Medical AG | 2017-09-20 | Traditional | PDF ↗ |
| K162242 | Comfort Flo Humidification System | Teleflexmedical, Inc. | 2017-01-19 | Traditional | PDF ↗ |
| K160764 | AirLife Autofill Humidification Chamber | Carefusion 2200, Inc. | 2016-08-25 | Traditional | PDF ↗ |
| K161314 | FLEXICARE FL-9000U RESPIRATORY HUMIDIFIER BASE | Flexicare Medical Limited. | 2016-07-06 | Traditional | PDF ↗ |
| K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 | Hamilton Medical AG | 2016-05-03 | Traditional | PDF ↗ |
| K143646 | MR810 System, 900MR810 Adult Single Limb Circuit, 900MR810E Adult Dual Limb Circuit | Fisher & Paykel Healthcare, Ltd. | 2015-03-05 | Traditional | PDF ↗ |
| K133766 | HUMICARE D900 | Gruendler GmbH | 2014-11-24 | Traditional | PDF ↗ |
| K141940 | CONCHASMART COLUMN | Teleflex, Inc. | 2014-11-24 | Traditional | PDF ↗ |
| K140556 | CONCHASMART BREATHING CIRCUIT | Teleflex, Inc. | 2014-09-24 | Traditional | PDF ↗ |
| K141353 | HUDSON RCI AQUAPAK HUMIDIFIER ADAPTOR | Teleflexmedical, Inc. | 2014-08-01 | Special | PDF ↗ |
| K132857 | RESPIRATORY GAS HUMIDIFIER | Pacific Medico Co., Ltd. | 2014-05-01 | Special | PDF ↗ |
| K132017 | HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT | Fisher & Paykel Healthcare, Ltd. | 2014-03-25 | Traditional | PDF ↗ |
| K131912 | CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN | Teleflex, Inc. | 2014-03-06 | Traditional | PDF ↗ |
| K131957 | MR810RESPIRATORY HUMIDIFIER, 900MR810 ADULT SINGLE LIMB CIRCUIT, 900MR810E ADULT DUAL LIMB CIRCUIT | Fisher & Paykel Healthcare, Ltd. | 2013-12-04 | Traditional | PDF ↗ |
| K131895 | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER | Fisher & Paykel Healthcare, Ltd. | 2013-10-24 | Traditional | PDF ↗ |
| K131388 | TRANSCEND HEATED HUMIDIFIER | Somnetics International, Inc. | 2013-09-26 | Traditional | PDF ↗ |
| K122885 | MEDISIZE GOLD HEATER AND BOOSTER T-PIECE | Medisize BV | 2013-08-29 | Traditional | PDF ↗ |
| K122705 | HUMICARE D900 | Grundler GmbH | 2013-05-21 | Traditional | PDF ↗ |
| K121975 | AIRVO HUMIDIFIER MYAIRO HUMIDIFIER | Fisher & Paykel Healthcare, Ltd. | 2013-01-03 | Traditional | PDF ↗ |
| K110019 | RESPIRATORY HUMIDIFER | Fisher & Paykel Healthcare, Ltd. | 2012-03-30 | Traditional | PDF ↗ |
| K113542 | SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) | Salter Labs, Arvin Facility | 2012-02-10 | Traditional | PDF ↗ |
| K111640 | PRECISION FLOW(R) - HELIOX | Vapotherm, Inc. | 2011-10-07 | Traditional | PDF ↗ |
| K103316 | FLOWREST | Vapotherm, Inc. | 2011-02-08 | Traditional | PDF ↗ |
| K093617 | VENTLAB 6000 SERIES HUMIDIFIER | Ventlab Corp. | 2011-01-27 | Traditional | PDF ↗ |
| K102618 | VENTSTAR HEATED, INFINITY ID BREATHING CIRCUIT HEATED | Draeger Medical AG & Co. KG | 2010-12-10 | Traditional | PDF ↗ |
| K092256 | THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 | Smiths Medical Asd, Inc. | 2010-10-20 | Traditional | PDF ↗ |
| K100554 | RESPIRATORY HUMIDIFIER , HEATED DELIVERY SYSTEM, ADAPTOR, MODELS MR880, RT241, 900MR441 | Fisher & Paykel Healthcare, Ltd. | 2010-05-28 | Traditional | PDF ↗ |
| K092846 | AIRVO SERIES HUMIDIFIERS | Fisher & Paykel Healthcare, Ltd. | 2010-01-27 | Traditional | PDF ↗ |
| K090915 | STERILE WATER FOR INHALATION FLEX BAG, USP | Cardinal Health, Inc. | 2009-11-18 | Traditional | PDF ↗ |
| K080149 | HEATER BASE, MODEL PMH7000 | Pacific Medico Co., Ltd. | 2008-12-18 | Traditional | PDF ↗ |
| K072845 | PRECISION FLOW | Vapotherm, Inc. | 2008-07-17 | Traditional | PDF ↗ |
| K080797 | HUMIDAIRE 2I | Resmed, Ltd. | 2008-07-09 | Traditional | PDF ↗ |
| K073706 | RESPIRATORY HUMIDIFIER, MODEL MR850 | Fisher & Paykel Healthcare, Ltd. | 2008-03-31 | Traditional | PDF ↗ |
| K072982 | PARI HYDRATE V | Pari Innovative Manufacturers, Inc. | 2007-11-29 | Traditional | PDF ↗ |
| K071958 | THERA-HEAT HEATED HUMIDIFIER AND ADULT DUAL AND SINGLE LIMB HEATED WIRE VENTILATOR BREATHING CIRCUITS | Smiths Medical Asd, Inc. | 2007-11-21 | Traditional | PDF ↗ |
| K070714 | MEDISIZE GOLD HEATER AND BOOSTER | Medisize BV | 2007-04-30 | Traditional | PDF ↗ |
| K063758 | CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R | Teleflex Medical | 2007-04-23 | Traditional | PDF ↗ |
| K070056 | VAPOTHERM MODEL# 2000I AND 2000H | Vapotherm, Inc. | 2007-04-13 | Special | PDF ↗ |
| K070107 | PARI HYDRATE G | Pari Innovative Manufacturers, Inc. | 2007-02-23 | Traditional | PDF ↗ |
| K062664 | HUMIDCARE HEATED HUMIDIFIER, MODEL 9S-004 | Apex Medical Corp. | 2006-12-06 | Traditional | PDF ↗ |
| K061736 | COMFORT FLO HUMIDIFICATION SYSTEM AND NASAL CANNULA | Teleflex Medical | 2006-08-18 | Traditional | PDF ↗ |
| K062091 | POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION | Porous Media Corp. | 2006-08-08 | Traditional | PDF ↗ |
| K060790 | BREAS, MODEL HA01 | Breas Medical AB | 2006-05-25 | Special | PDF ↗ |
| K052615 | MEDISIZE GOLD | Medisize BV | 2005-12-09 | Traditional | PDF ↗ |
| K050990 | REMREST HEATED HUMIDIFIER | Medical Industries America, Inc. | 2005-05-02 | Traditional | PDF ↗ |
| K050314 | AQUINOX | Smiths Medical Asd, Inc. | 2005-02-18 | Traditional | PDF ↗ |
| K042184 | GOODKNIGHT H20, MODEL M-114600-00 | Mallinckrodt Developpement France | 2005-01-10 | Traditional | PDF ↗ |
| K041963 | AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI | American Bantex Corp. | 2004-10-20 | Traditional | PDF ↗ |
| K042245 | VAPOTHERM MODEL#2000I, 200H | Vapotherm, Inc. | 2004-08-30 | Traditional | PDF ↗ |
| K020700 | PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY | Pegasus Research Corp. | 2004-04-26 | Traditional | PDF ↗ |
| K033710 | MR850 RESPIRATORY HUMIDIFIER, MODEL MR850JHU | Fisher & Paykel Healthcare, Ltd. | 2004-04-13 | Traditional | PDF ↗ |
| K031176 | INVACARE POLARIS EX HEATED HUMIDIFIER, MODEL ISP4000 | Invacare Corp. | 2004-03-25 | Traditional | PDF ↗ |
| K040507 | TAGA VELOCITY PASSOVER HUMIDIFIER WITH HEATER, MODEL TM1000H | Taga Medical Technologies, Inc. | 2004-03-04 | Traditional | PDF ↗ |
| K031179 | TAGA VELOCITY HUMIDIFIER | Taga Medical Technologies, Inc. | 2003-07-17 | Traditional | PDF ↗ |
| K031383 | MODEL 780 | Hudson Respiratory Care, Inc. | 2003-07-07 | Special | PDF ↗ |
| K020332 | RESPIRATORY HUMIDIFIER, MODEL MR850 | Fisher & Paykel Healthcare, Ltd. | 2003-07-07 | Traditional | PDF ↗ |
| K013486 | VAPOTHERM 2000H | Vapotherm, Inc. | 2003-05-30 | Traditional | PDF ↗ |
| K013856 | PMH 1000 HEATED HUMIDIFIER | Pegasus Research Corp. | 2003-02-21 | Traditional | PDF ↗ |
| K030090 | H2 HEATED HUMIDIFIER | Respironics, Inc. | 2003-01-24 | Traditional | PDF ↗ |
| K020900 | DEVILBISS MODEL 9200D HEATED HUMIDIFIER SYSTEM | Sunrise Medical Hhg, Inc. | 2002-06-03 | Traditional | PDF ↗ |
| K012633 | RESPIRONICS HEATED HUMIDIFIER | Respironics, Inc. | 2002-02-28 | Traditional | PDF ↗ |
| K003973 | RESPIRATORY HUMIDIFIER, MODEL HC150 | Fisher & Paykel Healthcare, Ltd. | 2001-06-01 | Traditional | PDF ↗ |
| K003626 | DEVILBISS HUMIDIFIER | Sunrise Medical Hhg, Inc. | 2001-05-04 | Traditional | PDF ↗ |
| K010578 | TAGA VELOCITY PASSOVER HUMIDIFIER UNIT, MODEL MP1017 | Taga Medical Technologies, Inc. | 2001-04-25 | Traditional | PDF ↗ |
| K003561 | INVACARE PASSOVER HUMIDIFIER MODEL ISP9700 | Invacare Corp. | 2001-04-17 | Traditional | PDF ↗ |
| K010402 | SMOOTH-FLO CIRCUIT | Hudson Respiratory Care, Inc. | 2001-03-14 | Special | PDF ↗ |
| K002454 | BREAS HA50 HUMIDIFIER, MODEL HA50 | Vital Signs, Inc. | 2001-03-07 | Abbreviated | PDF ↗ |
Product code BTT · Class II · Anesthesiology. Data: openFDA.